Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Myocardial Infarction (MI) Patient
Comparison the Therapeutic Outcomes of Bone Marrow Derived AC 133+ and Mono-Nuclear Cells (MNC) Implantation in Patient With Acute Myocardial Infarction Underwent PCI Procedure
1 other identifier
interventional
80
1 country
1
Brief Summary
Although a percutaneous coronary intervention (PCI) can be used to open up the blocked artery and restore blood flow to the heart muscle after myocardial infarction, there may be a significant amount of heart tissue that has been irreversibly damaged. Recent studies have shown that adult stem cells from bone marrow may be able to improve heart function and prevent from heart remodeling due to heart failure. This study will evaluate the safety and effectiveness of using adult bone marrow derived stem cells for improving heart function in MI patients with Left Anterior Descending (LAD) involvement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2009
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 18, 2010
CompletedFirst Posted
Study publicly available on registry
August 24, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedDecember 27, 2012
August 1, 2010
3.3 years
August 18, 2010
December 25, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Increase from baseline in ejection fraction
6 months
Secondary Outcomes (2)
Decrease LVESV/LVEDV/LVM index
6 months
Decrease the number of Non Viable segments from baseline
6 months
Study Arms (3)
AC133 recipients
EXPERIMENTALintra coronary injection of bone marrow derived AC133+ cells
MNC recipients
EXPERIMENTALintra coronary injection of bone marrow derived MNC
control
ACTIVE COMPARATORinjection of autologous serum
Interventions
Eligibility Criteria
You may qualify if:
- BMI\> 30
- First acute MI in LAD territory
- St elevation MI
- Ejection fraction: 20-45%
- at least two non - mobile or less mobile segment of left ventricular myocard.
- Successful PCI with stenting
You may not qualify if:
- Multivessel ceremony artery disease
- Pulmonary edema
- SBP \< 80 mmHg
- Thrombocytopenia (PLT \< 50, 000)
- INR \> 2
- Hepatic failure or dysfunction
- Renal failure or dysfunction
- Positive HIV Ab/ HBC Ab/ HCV Ab/ HSV Ag
- Documental terminal illness
- Documental Malignancy
- Patient with sever coronary disease and unstability of vital sign
- History of leukopenia, Anemia, hepatic or renal dysfunction or malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
Royan institute
Tehran, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hamid Gourabi, PhD
Royan Institute
- PRINCIPAL INVESTIGATOR
Masoud Ghassemi, MD
Royan Institute
- STUDY DIRECTOR
Nasser Aghdami, PhD,MD
Royan Institute
- PRINCIPAL INVESTIGATOR
Davood Kazemi saleh, MD
Royan Institute
- PRINCIPAL INVESTIGATOR
Hossein Baharvand, PhD
Royan Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2010
First Posted
August 24, 2010
Study Start
May 1, 2009
Primary Completion
September 1, 2012
Study Completion
December 1, 2012
Last Updated
December 27, 2012
Record last verified: 2010-08